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romiplostim

Generic: romiplostim·Brand: Nplate

romiplostim: sourced relationships with 1 company · 4 clinical trials tracked · 1 FDA decision.

romiplostim evidence translation

What we can confirm

1 FDA record · 4 tracked trials

What it means

Source-backed records connect romiplostim to AMGN; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could romiplostim → AMGN affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence4 indications · 0 study sponsors

Related indications

Primary Immune Thrombocytopenia; Chemotherapy-induced ThrombocytopeniaMyelofibrosisPrimary Immune ThrombocytopeniaThrombocytopenia

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (1)
CompanyDated record stage
AMGEN INC (AMGN)
Reported 2008-08-22 · Current development: unknownSource
Primary Immune Thrombocytopenia; Chemotherapy-induced Thromb…
Phase 3
Clinical Trial Registry Records (4)

A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP).

NCT07700238Registry updated 2026-09-17·Phase 3·AMGN
Recruiting

Primary endpoint: Percentage of Participants With a Durable Platelet Response (DPR)

InterventionalRandomizedopen126 targetStarted 2026-08Completion 2029-103 sites · United StatesAmgen

High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly

NCT06345495Registry updated 2026-09-16·Phase 2
Recruiting

Primary endpoint: Safety and adverse events (AEs)

Interventionalopen30 targetStarted 2024-10Completion 2029-011 site · United StatesM.D. Anderson Cancer Center

Romiplostim for Prevention of Severe Chemotherapy Induced Thrombocytopenia in Lymphoma Patients - Phase II Study

NCT04673266Registry updated 2026-04-13·Phase 2
Completed

Primary endpoint: measure of incidence of indication for dose delays

Interventionalopen11 enrolledStarted 2020-12Completion 2026-047 sites · United StatesMemorial Sloan Kettering Cancer Center

PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

NCT03937154Registry updated 2026-04-07·Phase 3·AMGN
Active, not recruiting

Primary endpoint: Incidence of either a chemotherapy dose delay or reduction

InterventionalRandomizedquadruple145 targetStarted 2020-02Completion 2027-0250 sites · Argentina, Austria, Brazil, Bulgaria…Amgen
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]). ( 1.2 ) Limitations of Use: Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts. ( 1 ) 1.1 Patients with Immune Thrombocytopenia (ITP) Nplate is indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 1.2 Patients with Hematopoietic Syndrome of Acute Radiation Syndrome Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.3) ] . Limitations of Use: Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP [see Warnings and Precautions ( 5.1 )] . Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts [see Warnings and Precautions ( 5.2 )] .(AMGN)FDA ↗
BLA125268Type 1 - New Molecular EntityOrphan DrugPrioritySubcutaneousInjectable

Frequently asked questions

Which companies have sourced relationships with romiplostim?

romiplostim has dated SEC/FDA relationship records for AMGEN INC.

How many clinical trials involve romiplostim?

BioSniper tracks 4 clinical trials involving romiplostim.

What is romiplostim's latest FDA decision?

The most recent tracked FDA decision for romiplostim is Approval for 1 INDICATIONS AND USAGE Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]). ( 1.2 ) Limitations of Use: Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP. Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts. ( 1 ) 1.1 Patients with Immune Thrombocytopenia (ITP) Nplate is indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 1.2 Patients with Hematopoietic Syndrome of Acute Radiation Syndrome Nplate is indicated to increase survival in adults and in pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation [see Clinical Studies (14.3) ] . Limitations of Use: Nplate is not indicated for the treatment of thrombocytopenia due to myelodysplastic syndrome (MDS) or any cause of thrombocytopenia other than ITP [see Warnings and Precautions ( 5.1 )] . Nplate should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk for bleeding. Nplate should not be used in an attempt to normalize platelet counts [see Warnings and Precautions ( 5.2 )] ., dated August 22, 2008.